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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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|
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| GDL1
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| 01/18/2006
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| 01/18/2006
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| Federal Government
|
| Guidance: Labeling for Human Prescription Drug and Biological Products -- Implementing the New Conte
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| pdf
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| GDL2
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| 01/18/2006
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| 01/18/2006
|
| Federal Government
|
| Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription drugs
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|
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| pdf
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| Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Productgs -- Content and Format
|
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| NAD1
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| 01/18/2006
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| FDA
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| FDA
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| 01/24/2006
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| 3998-3999
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| 04/18/2006
|
| htm | pdf
|
|
|
|
|
| Signature:
|
| Jeffrey Shuren
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|
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| C1
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| 03/06/2006
|
| 03/02/2006
|
| Health Care Association
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| American Optometric Association (AOA)
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|
| pdf
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|
|
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|
| Signature:
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| Richard L. Wallingford, Jr. OD
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|
|
|
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|
| EMC1
|
| 04/18/2006
|
| 04/18/2006
|
| Drug Industry
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| Abbott Laboratories (Abbott)
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|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Douglas L. Sporn
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|
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| C2
|
| 04/21/2006
|
| 04/21/2006
|
| Drug Industry
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| Sanofi-aventis U.S., Inc.
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|
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|
|
|
|
| pdf
|
|
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| Signature:
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| Mark W. Moyer
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| C3
|
| 04/21/2006
|
| 04/21/2006
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| Drug Industry
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| Wyeth Pharmaceuticals, Inc.
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|
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|
| pdf
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| Signature:
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| Roy J. Baranello, Jr.
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|
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| C4
|
| 04/21/2006
|
| 04/20/2006
|
| Drug Industry
|
| Bristol-Myers Squibb Company (BMS)
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|
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|
| pdf
|
|
|
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|
| Signature:
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| Richard L. Wolgemuth, PhD
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|
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| C5
|
| 04/21/2006
|
| 04/20/2006
|
| Drug Industry
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| Bristol-Myers Squibb Company (BMS)
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|
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|
| pdf
|
|
|
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| Signature:
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| Richard L. Wolgemuth, PhD
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| EMC2
|
| 04/20/2006
|
| 04/20/2006
|
| Private Industry
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| Amgen Regulatory Affairs
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|
| txt
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| Signature:
|
| Jenny Peters
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|
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|
| EMC3
|
| 04/21/2006
|
| 04/21/2006
|
| Private Industry
|
| Amgen Regulatory Affairs
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|
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|
|
| txt
|
|
|
|
|
| Signature:
|
| Jenny Peters
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|
|
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|
| EMC4
|
| 04/24/2006
|
| 04/24/2006
|
| Drug Industry
|
| Merck & Co., Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Taryn Rogalski-Salter, PhD
|
|
|
|
|
| EMC5
|
| 04/24/2006
|
| 04/24/2006
|
| Drug Industry
|
| Johnson & Johnson Pharmaceutical Research & Development, LLC
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|
|
|
|
|
|
| pdf
Attachment |
|
|
|
|
| Signature:
|
| Freddy A. Jimenez
|
|
|
|
|
| C6
|
| 04/25/2006
|
| 04/25/2006
|
| Drug Industry
|
| Schering-Plough
|
|
|
|
|
|
|
| pdf
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|
|
|
|
| Signature:
|
| Gretchen Trout
|
|
|
|
|
| C7
|
| 05/01/2006
|
| 04/24/2006
|
| Drug Industry
|
| Lilly Research Laboratories (Lilly)
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|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Leslie D. Carter, PharmD
|
|
|
|
|
| EMC6
|
| 04/25/2006
|
| 04/25/2006
|
| Drug Industry
|
| Biotechnology Industry Organization (BIO)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Sara Radcliffe
|
|
|
|
|
| EMC7
|
| 04/28/2006
|
| 04/28/2006
|
| Drug Industry
|
| Biotechnology Industry Organization (BIO)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Sara Radcliffe
|
|
|
|
|
|
